D-0003-2015 Class II Terminated

Recalled by New England Home Therapies, Inc — Southborough, MA

FDA drug recall D-0003-2015 was initiated by New England Home Therapies, Inc on February 26, 2014 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: All compounded products. The recall status is terminated (terminated August 17, 2016). Affected quantity: 87 Products.

Recall Details

Product Type
Drugs
Report Date
October 8, 2014
Initiation Date
February 26, 2014
Termination Date
August 17, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
87 Products

Product Description

All sterile drugs compounded between 2/21/14 and 2/24/14.

Reason for Recall

Lack of Assurance of Sterility: All compounded products.

Distribution Pattern

US: New England

Code Information

Expiration dates between 3/5/14 and 3/10/14.